Phase II Clinical Trial of Preoperative Chemoradiotherapy for Resectable Pancreatic Cancer

JRCT ID: jRCT1052240120

Registered date:04/09/2024

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: Pancreatic cancer
• Date of first enrollment: 04/09/2024
• Target sample size: 50
• Study type: Interventional

Intervention(s)

As induction chemotherapy, one or two courses of chemotherapy with gemcitabine hydrochloride (GEM) and S-1 (GS therapy) are administered, followed by neoadjuvant chemoradiotherapy. Specifically, GEM is administered as a drip infusion at a dose of 1000 mg/kg on days 1 and 8, with a rest period on day 15. S-1 is taken orally for one week starting from the day of GEM administration. One course consists of these three weeks. If it becomes difficult to administer the treatment on the scheduled days due to holidays or other reasons, the treatment may be postponed to the following day or later. In principle, GS therapy consists of one course, but depending on the situation, such as the preparation period for radiation therapy, up to two courses are permitted.

For concurrent chemoradiotherapy (IMRT), either GEM or S-1 is used as the concurrent drug. If GEM is the concurrent drug, it is administered on days 22, 29, and 36, starting with the initiation of IMRT on day 22 (on days 43, 50, and 57 if GS therapy is extended to two courses).

Outcome(s)

• Primary Outcome: Overall survival
• Secondary Outcome: Recurrence-free survival, recurrence pattern of the tumor, R0 resection rate, postoperative complication rate, Evans grade, treatment-related mortality rate, preoperative and postoperative treatment completion rate

Key inclusion & exclusion criteria

• Age minimum: >= 20age old
• Age maximum: < 80age old
• Gender: Both

Include criteria

1) Diagnosed with adenocarcinoma or adenosquamous carcinoma based on pathological examination.
2) Classified as resectable pancreatic cancer based on the pancreatic cancer resectability classification.
3) The CA19-9 level is below 100 U/ml in the pre-registration examination. The CA19-9 level is referenced as measured when the serum total bilirubin level is 3.0 mg/dL or less.
4) The patient's age is between 20 and 80 years on the day of registration.
5) ECOG Performance Status (PS) is 0 or 1.
6) The patient is judged to be capable of undergoing radical resection for pancreatic cancer.
7) The most recent tests within 14 days before registration meet all of the following criteria: White blood cell count greater than or equal to 3500 per microliter or neutrophil count greater than or equal to 2000 per microliter, Hemoglobin level greater than or equal to 8.0 g/dL, Platelet count greater than or equal to 75000 per microliter, AST less than or equal to 200 IU/L ALT less than or equal to 200 IU/L, T-Bil less than or equal to 2.0 mg/dL (For cases that have undergone biliary drainage for obstructive jaundice, T-Bil less than or equal to 3.0 mg/dL), Creatinine less than or equal to 1.5 mg/dL
8) Written informed consent for trial participation has been obtained from the patient.

Exclude criteria

1) Has a history of receiving radiation therapy to the upper abdomen.
2) Has active double cancer (synchronous double cancer or metachronous double cancer with a disease-free interval of less than 3 years).
*Carcinoma in situ and intramucosal carcinoma lesions are not considered active double cancer, and registration is allowed.
3) Has direct tumor invasion reaching the mucosal surface of the stomach, duodenum, or small intestine.
4) Has pulmonary fibrosis or interstitial pneumonia.
5) Has scleroderma, mixed connective tissue disease, or active systemic lupus erythematosus (SLE).
6) Has serious comorbidities, such as heart failure, renal failure, liver failure, hemorrhagic peptic ulcer, paralytic ileus, intestinal obstruction, or uncontrollable diabetes.
7) Has a history of blood transfusion within 14 days prior to registration.
8) Pregnant, possibly pregnant, wishing to become pregnant, or breastfeeding, or is a male wishing for their partner to become pregnant.
9) Is receiving continuous systemic administration (oral or intravenous) of steroids or other immunosuppressants.
10) Has unstable angina (angina with onset or worsening within the last 3 weeks) or a history of myocardial infarction within the past 6 months.
11) Has a history of severe drug hypersensitivity to either gemcitabine or S-1.
12) Has a mental illness or psychiatric symptoms that interfere with daily life, making participation in the trial difficult.
13) Has an infection requiring systemic treatment (excluding viral hepatitis).

Related Information

• Primary Sponsor: Hatano Etsuro
• Secondary Sponsor: Anazawa Takayuki